BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE

    MDR report key: 23864498 · Received December 22, 2025

    Report

    Report Number
    0008010720-2025-01788
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    UDI-DI
    04053815076698
    PMA / PMN Number
    K251378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY TREATMENT OR MEDICAL INTERVENTION REQUIRED FOR THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOTONE TREATMENT TO THE ABDOMEN AND PRESENTED WITH A "BURN" POST TREATMENT. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY TREATMENT OR MEDICAL INTERVENTION REQUIRED FOR THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. DISTRIBUTOR TRIED TO CONTACT HEALTHCARE PROVIDER TO COLLECT MORE INFORMATION WITHOUT RESULT. SO, CIRCUMSTANCES AND DEGREE OF BURN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875556 COOLTONE STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING, PRODUCT CODE: NGX NGX ZIMMER MEDIZINSYSTEME GMBH 5034 04053815076698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention